Comments to USPSTF re: Nutrition and Behavioral Counseling for Cardiovascular Disease Risk Factors

 June 9, 2014

Michael L. LeFevre, M.D., M.S.P.H.
Chair, United States Preventive Services Task Force
540 Gaither Road
Rockville, MD
20850

Re: Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors

Dear Dr. LeFevre:

The Academy of Nutrition and Dietetics appreciates the opportunity to submit comments to the United States Preventive Services Task Force (USPSTF) related to its May 13, 2014 Draft Recommendation Statement for Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors (“Draft Recommendation”).1 With over 75,000 members comprised of registered dietitian nutritionists (RDNs),2 dietetic technicians, registered (DTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States committed to improving the nation’s health through food and nutrition across the lifecycle. The Academy’s member RDNs independently provide nutrition care services, including Medical Nutrition Therapy,3 to individuals with a wide variety of disease states and chronic conditions. Such services are covered benefits under Medicare (diabetes, renal disease, post-kidney transplant upon referral from a physician), some state Medicaid programs, and many private payers.

I. Support of the Substance of the Draft Recommendation

The Academy generally supports the Draft Recommendation, particularly its recognition of the importance of “referring overweight or obese adults who have additional cardiovascular disease (CVD) risk factors to intensive behavioral counseling interventions to promote a healthy diet and physical activity for CVD prevention.”4 We agree with the USPSTF’s conclusion “that for overweight or obese adults at increased risk of CVD, intensive behavioral counseling had a moderate benefit on risk for CVD, including improvements in body mass index (BMI), blood 2

pressure, lipids, fasting glucose, and levels of physical activity [and that t]he reduction in glucose levels was sufficient to lead to a lower incidence of the diagnosis of diabetes.”5 The USPSTF’s 2014 Evidence Review6 clarifies that both medium- and high-intensity interventions improve intermediate CVD health outcomes, but that only high-intensity interventions “reduced diabetes incidence in the longer-term.”7 Findings of the Academy’s Evidence Analysis Library MNT Effectiveness Project comport with the USPSTF’s conclusions.8

The Draft Recommendation and the 2014 Evidence Review affirm that RDNs were typically providers of the effective nutrition therapies upon which the USPSTF based its recommendations. This is consistent with the findings of the Institute of Medicine, which concluded “the registered dietitian is currently the single identifiable group of health-care professionals with standardized education, clinical training, continuing education and national credentialing requirements necessary to be directly reimbursed as a provider of nutrition therapy.”9 The Academy is confident that the USPSTF’s Grade B recommendation, when finalized, should result in broader coverage of RDN-provided Medical Nutrition Therapy, thereby improving access to the effective care the USPSTF recommended.

Although the Draft Recommendation purports to be “an update of the USPSTF’s 2003 recommendation for dietary counseling in adults with CVD risk factors (B recommendation)[, . . .] this new recommendation targets overweight and obese adults with additional CVD risk factors (e.g., hypertension, dyslipidemia, impaired fasting glucose, metabolic syndrome).”10 In contrast, the USPSTF’s 2003 recommendation for Behavioral Counseling in Primary Care to Promote a Healthy Diet (the “2003 Recommendation”) does not require that patients have obesity or overweight, but only “hyperlipidemia and other known risk factors for cardiovascular and diet-related chronic disease.”11 Given that the selected classes in this Draft Recommendation and the 2003 3

Recommendation are different, the Academy urges the USPSTF not to disavow its prior recommendation from 2003.

The Academy supports the USPSTF’s recognition that high intensity interventions provided by specialized practitioners, such as RDNs, outside of the primary care setting are usually most effective. In addition, we encourage USPSTF to incorporate studies and recommendations from recently published evidence reviews and guidelines and to differentiate protocol-based behavioral counseling from more complex individualized Medical Nutrition Therapy, the latter of which is a recognized necessary and effective component of care for individuals with multiple chronic conditions (including the aforementioned risk factors for CVD).

II. USPSTF: Factors in Effective Interventions

Since 1996, the USPSTF and affiliated researchers have undertaken a series of evidence reviews and systematic evidence updates analyzing available studies related to dietary interventions and counseling to promote a healthy diet. These reviews identify intensity of intervention (minutes in a session) as the most significant factor; after intensity, the most consistent factors of effective interventions are the specialized qualifications of the provider and the provision of services at a venue being outside the primary care setting. The largest changes in diet come from interventions conducted by a registered dietitian nutritionist or other specially trained practitioner conducted outside of the primary care setting.

A. Intensity of Intervention

The USPSTF has consistently identified the intensity of intervention (number of minutes; frequency of sessions) as the most significant factor in explaining differences in effects from dietary intervention trials:

“Both medium- and high-intensity interventions reduced lipids, blood pressure, and measures of weight. High-intensity interventions reduced glucose and incidence of diabetes. In general, effective counseling interventions were intensive and involved several hours (median 13 hours [IQR 9 to 19 hours]), over several contacts (median 8 contacts [IQR 5 to 16 contacts]), over several months duration (median 12 months duration [IQR 6 to 12 months]).”12 “Effective interventions were medium- to high-intensity combined lifestyle or diet only counseling interventions. Medium-intensity interventions are defined as greater than 30 up to 360 minutes of contact. Approximately two-thirds of the medium-intensity interventions had 120 minutes or more of contact time; the median number of contacts was five and median duration of intervention was 9 months.”13 “Most interventions evaluated combined counseling for a healthy diet and physical activity and were intensive with multiple ‘contacts’ (which may include individual or group counseling sessions) over extended periods of time. The interventions averaged 5 to 16 contacts over a period of 9-12 months depending upon the intensity of the intervention. . . . High-intensity interventions were those having greater than 360 minutes of contact; the median number of contacts was 16 and median duration of intervention was 12 months. Specially trained individuals delivered these interventions, including dietitians or nutritionists, physiotherapists or exercise professionals, as well as health educators, nurses, or psychologists.”14 The largest effect of dietary counseling in asymptomatic adults has been observed with more intensive interventions (multiple sessions lasting 30 minutes or longer) among patients with hyperlipidemia or hypertension and among others at increased risk of diet-related chronic disease.15 In our review, virtually all studies achieving large effect sizes fell into the high-intensity category. . . . Low intensity counseling interventions, such as those typically used in primary care settings, . . . achieved only small to medium effects on dietary behavior.16

The Academy wholly supports the USPSTF’s Grade B recommendation for high intensity interventions and encourages payers to integrate the recommendation into their policies consistent with the USPSTF’s definition of high intensity to achieve the desired results and proven benefits.

B. Provider Type/Expertise

After intensity, the specialized skills or type of practitioner conducting interventions is the second most significant factor in producing statistically significant improvements in dietary change or physiological results in most trials. The USPSTF concluded that successful “[i]interventions were delivered by specially trained individuals including dieticians [sic] or nutritionists, physiotherapists or exercise professionals, health educators, psychologists, and other trained professionals.”17 In the two well-researched interventions discussed in depth in the Draft Recommendation, providers (even when classified as “lifestyle coaches”) were specialized experts—either registered dietitian nutritionists or masters-level trained interventionists.18 In addition, the 2014 Evidence Review concluded that “dietary counseling practices of primary care clinicians fall short of recommendations, even for patients at high risk of CVD.”19 The underlying evidence review for the 2003 Recommendation reached the same conclusion that “[a]lmost all of the effective medium- to high-intensity interventions were delivered by specially trained health educators or nurses, counselors or psychologists, dietitians or nutritionists, or exercise instructors or physiologists. Very few of these interventions involved the primary care physician at all.”20 It is critical to ensure that the specially trained practitioners able to deliver the results found in the reviewed studies are actually able to provide the interventions.

The Academy believes primary providers play a critical role in the screening and referral of patients with risk factors for cardiovascular disease as an important first step in preventing or minimizing the progression of chronic disease. Primary care providers are limited in their time, training, and skills to conduct the medium or high-intensity interventions that are scientifically proved to be the most effective in producing the largest, most lasting results. It is both cost-effective and efficient to have primary care provider-driven referrals of patients with risk factors for CVD to practitioners skilled in conducting dietary interventions who practice both inside and outside of primary care settings. The Institute of Medicine recognizes that “the registered dietitian [nutritionist] is currently the single identifiable group of health-care professionals with standardized education, clinical training, continuing education and national credentialing requirements necessary to be directly reimbursed as a provider of nutrition therapy.”21 Thus, the Academy asks that the USPSTF explicitly recommend appropriate referrals from primary care providers to registered dietitian nutritionists or other specialists for effective dietary interventions as it did in its 2003 recommendation.

The Academy wholly supports the USPSTF’s Grade B recommendation for interventions to be provided upon referral to registered dietitian nutritionists or other specialized practitioners and encourages payers to integrate the recommendation into their policies to achieve the desired results and proven benefits.

C. Venue/Location

The Academy recognizes that the qualifications, skills, education, training, and credentials of the practitioner delivering the service is more important in assuring effectiveness than the service location, but appreciates that both current and newer models of health care delivery affirm the importance of the primary care provider (PCP) coordinating care while recognizing that the PCP does not deliver all of the care. Instead, PCPs rely upon a team that is not bound by physical walls, but rather connected through coordination, communication, and technology.

Similarly, USPSTF’s behavioral counseling recommendations are either “feasible for primary care delivery or are available for referral from primary care and delivered in other settings,”22 which the Draft Recommendation refers to as “primary care-relevant.” The 2014 Evidence Review concluded that “[g]iven the intensity and expertise needed for these interventions, the counseling interventions evaluated are primarily referable from primary care, as opposed to delivered in primary care.”23 The USPSTF also recognizes that it is the “less intensive counseling that may be delivered in the primary care setting” and noted that additional research is needed to ascertain whether interventions conducted in the primary care setting are even effective.24 The Academy agrees with these conclusions and asks that the USPSTF explicitly recommend that recommended intensive interventions be primary-care relevant, or referable outside of the primary care setting.

The Draft Recommendation confirms that both of the “[t]wo well-researched interventions” (The DPP and PREMIER studies) discussed in detail in the Draft Recommendation are typically provided by registered dietitian nutritionists or other appropriately trained professionals. And although the Draft Recommendation notes that these two interventions “could be delivered feasibly in the primary care setting or by local community providers[,]”25 the Academy notes that the 2014 Evidence Review specifically “excluded interventions delivered through non-referable community settings (e.g., work sites, churches).”26 Thus, given that the 2014 Evidence Review excluded studies of their effectiveness, we seek clarification that the USPSTF’s recommendation does not include interventions at non-referable community settings.

The Academy wholly supports the USPSTF’s Grade B recommendation for effective primary care relevant intensity interventions outside of the primary care setting and encourages payers to integrate the recommendation into their policies to achieve the desired results and proven benefits.

III. Importance of Individualized Intensive Behavioral Therapies

A. Relevance of New Guidelines

In November 2013 the American Heart Association, American College of Cardiology, and The Obesity Society published two guidelines directly relevant to the Draft Recommendation “based on the highest quality evidence available”27 from 1998-2009, although the timing of those guidelines likely precluded the USPSTF from considering them when preparing its Draft Recommendation.28 Both sets of guidelines are highly relevant to the USPSTF as it finalizes its recommendation and should be incorporated. Although the “AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults” evaluates interventions for weight loss, the studies reviewed meet the parameters specified in the 2014 Evidence Review and should thus be considered given the Draft Recommendation’s focus on individuals with overweight and obesity.29 The 2014 Evidence Review notably excluded studies where obesity was the only CVD risk factor, but the AHA/ACC/TOS Guidelines specify that “critical issues identified included . . . the impact of weight loss on risk factors for CVD and type 2 diabetes as well as CVD morbidity and mortality.”30

B. Tiers of Intensive Behavioral Counseling

The AHA/ACC/TOS Guidelines frequently differentiate between “trained interventionists” and “nutrition professionals” in evaluating studies and classifying types of behavioral and dietary interventions. Trained interventionists (who are frequently RDNs but also include “psychologists, exercise specialists, health counselors, or professionals in training”31) provide lifestyle/behavior modification by “adher[ing] to formal protocols” that are an appropriate and effective starting point for most patients with overweight or obesity.

However, the AHA/ACC/TOS Guidelines specify that highly skilled and differently trained “nutrition professionals” are required for more complex Medical Nutrition Therapy interventions: (1) when a specialized diet (for CVD risk reduction, diabetes, other medical condition) is prescribed; (2) when “a high-intensity comprehensive lifestyle intervention program is not available or feasible;” and (3) when the patient is unable to meet weight or targeted health goals through the lifestyle/behavior modification using formal protocols.32 In the studies that formed the evidence base for the AHA/ACC/TOS Guidelines, a “nutrition professional” was usually a registered dietitian nutritionist who “delivered the dietary guidance. . . .”33 When a patient has multiple co-morbidities or risk factors requiring diet and behavior modification, he or she needs the expertise of the RDN to individually tailor nutrition care, as formal protocols may actually conflict. The RDN’s expertise is invaluable in situations with increased complexity of decision-making, nutrition care planning, and coordination of care. Prescription and provision of therapeutic diets may be necessary. Depending on the nature of the diseases/conditions present, the degree of dietary modification indicated may be confusing and sometimes conflicting, (i.e. more fruits/vegetables, less Vitamin K) making dietary recommendations and patient compliance more difficult and necessitating the involvement of nutrition experts such as RDNs.

The Academy agrees with AHA and ACC that “[t]he ultimate decision about care of a particular patient must be made by the healthcare provider and patient in light of the circumstances presented by that patient[,]”34 which manifests the need for qualified, independent practitioners such as RDNs to provide more complex, individualized care when formal intervention programs or protocols may be unavailable, ineffective, or non-indicated.

The AHA/ACC/TOS Guidelines make the following specific relevant recommendations:

Recommendation 3b with a Grade of A (Strong): “Prescribe a calorie-restricted diet, for obese and overweight individuals who would benefit from weight loss, based on the patient’s preferences and health status and preferably refer to a nutrition professional for counseling.” “All patients for whom weight loss is recommended should be offered or referred for comprehensive lifestyle intervention (Box 11a and 11b). Comprehensive lifestyle intervention, preferably with a trained interventionist or nutrition professional is foundational to weight loss (Box 11a), regardless of augmentation by medications or bariatric surgery.” “The most effective behavioral weight loss treatment is in-person, high-intensity (i.e., ≥14 sessions in 6 months) comprehensive weight loss interventions provided in individual or group sessions by a trained interventionist (CQ4). “In primary care offices where frequent, in-person individual or group [lifestyle intervention] sessions led by a trained interventionist or a nutrition professional are not possible or available by referral, the physician may consider alternative modes of delivery. . . . An additional option if a high-intensity comprehensive lifestyle intervention program is not available or feasible is referral to a nutrition professional for dietary counseling.” “By expert opinion, if patients are unable to lose enough weight to meet weight or targeted health outcome goals with their current treatment, consider offering or referring for more intensive behavioral treatment than currently being attempted. . . .” In studies to date, low to moderate-intensity lifestyle interventions for weight loss provided to overweight or obese adults by primary care practices alone, have not been shown to be effective. Strength of Evidence: High”

C. Additional Evidence Supporting RDN-Provided Nutrition Therapy

(1) Dyslipidemia

The USPTSF’s Grade B recommendation of intensive dietary behavioral counseling supports nutrition services for hyperlipidemia and other known risk factors for cardiovascular and diet-related diseases, which includes other forms of dyslipidemia in addition to hyperlipidemia, namely lowered HDL-cholesterol.35 RDN-provided MNT produces beneficial changes in adiposity and lipids, as well as improvements in self-reported behavioral outcomes.36

In studies and reports, health experts and advocacy organizations cite the importance of having physicians refer patients/clients with dyslipidemia to RDNs or other qualified nutritionists for MNT intervention.37 As the various presentations of dyslipidemia respond to differing dietary interventions,38 39 40 the importance of utilizing the services of a health professional specifically trained to individualize treatment is of paramount importance.

A multitude of studies not included in the recent evidence review have demonstrated that MNT provided by an RDN has a positive impact on dyslipidemia and other cardiovascular risk factors in both individualized and RDN-led group settings. Additional research demonstrates improved treatment outcomes if the intervention includes an RDN as part of the intervention team versus interventions which do not include an RDN (Holmes et al, 2005; Henkin et al, 2000). Of these studies, those that conducted a cost-benefit analysis of RDN services found a savings in health care dollars spent due to decreased use of medications (Delahanty et al, 2001; Sikand et al, 2000; Sikand et al, 1998).41

Shai et al, 2008 investigated the effects of three dietary interventions utilized over the course of 2 years on BMI, blood lipid levels, and other cardiovascular risk factors. RDNs conducted 90-minute dietary intervention group sessions for each intervention group and conducted 10-15 minute motivational telephone calls for participants having trouble with adherence. Statistically significant improvements were seen in HDL-cholesterol and triglycerides in all groups, along with reductions in blood pressure and BMI. Holmes et al, 2005 examined the effectiveness of having RDN-led education and counseling compared to general education provided by cardiac rehabilitation. Education from a registered dietitian nutritionist was associated with improvements in total cholesterol, LDL cholesterol and triglycerides, along with reduced BMI. The general education intervention did not result in significant improvements in cardiac-related biomarkers. In Delahanty et al, 2001, patients with high cholesterol received either MNT from an RDN or usual care from a physician. RDN-led MNT achieved a greater decrease in total and LDL cholesterol levels, as well as greater weight loss, when compared with usual care. In Henkin et al, 2000, researchers examined the differences between patients with high cholesterol who received dietary counseling from both an RDN and a physician as compared to usual care from a physician only. The researchers determined that an intervention that includes an RD is more effective at lowering LDL-cholesterol levels in the short term than a physician-only intervention. In Sikand et al, 2000, researchers conducted a chart review on male patients with hyperlipidemia who had two to four individualized RDN visits over an eight-week period. Statistically significant improvements were seen in total cholesterol, LDL cholesterol, triglycerides, and BMI compared to baseline for patients who completed two to four MNT sessions with an RDN. As a result of MNT, 50% of eligible patients did not need cholesterol-lowering medication therapy. In Sikand et al, 1998, researchers conducted a chart review of patients who met criteria for initiating lipid-lowering drug therapy. For patients who completed two to four MNT sessions with an RDN, total cholesterol, LDL-cholesterol, and triglycerides decreased. LDL-cholesterol decreased more with four RDN visits compared with two RDN visits. (2) Hypertension Lifestyle and nutrition modifications, such as those included in MNT sessions, play a crucial role in both preventing and controlling hypertension. As the USPSTF appreciates, the link between hypertension and increased risk of CVD is clear. Nutrition and lifestyle changes produced through RDN-provided MNT can improve blood pressure control and thus decrease the risk of associated health complications.42 Studies not included in the recent evidence review have also shown that MNT provided by an RDN targeted specifically to sodium reduction can effectively reduce dietary sodium intake and lower blood pressure in older adults with hypertension (Appel et al, 2001; Applegate et al, 1992). In further studies, MNT provided by an RDN resulted in lifestyle changes contributing to reduced blood pressure (Pritchard et al, 1999).43 In Appel et al, 2001, older adults with hypertension received RDN-led group education in dietary sodium reduction. The reduced dietary sodium groups achieved and maintained a substantial reduction in dietary sodium, resulting in a reduction in systolic and diastolic blood pressure when compared to the usual lifestyle group. In Applegate et al, 1992, researchers investigated the effectiveness of non-pharmacologic interventions in older adults with hypertension. Intervention sessions were led by an RDN and combined weight reduction, sodium restriction and increased physical activity. The intervention group experienced greater reductions in systolic and diastolic blood pressure than did the control group.

(3) Prediabetes/Impaired Fasting Glucose as a Risk Factor

The Academy requests that USPSTF consider including impaired glucose homeostasis in the final recommendation statement as an indication for persons with increased CVD risk who would benefit from behavioral intervention. Impaired glucose homeostasis includes impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and elevated A1C, which are pathologic metabolic states—commonly referred to as prediabetes—and indicators for being at risk for developing type 2 diabetes.9 In the United States, elevated A1C and impaired fasting glucose are most commonly used as indicators for prediabetes or being at risk for diabetes. In fact, the A1C test is increasingly recognized by the medical community and professional associations as the test of choice because it is accurate, convenient and inexpensive.10 As of 2010, an estimated 79 million Americans—35 percent of adults aged 20 and older—had prediabetes based on fasting glucose or A1C levels, which increases their risk of CVD compared to persons with normal range glucose metabolism.1

IV. REVISING THE USPSTF’S DRAFT RECOMMENDATION IN LIGHT OF ITS STATUTORY ROLE

The Academy applauds the USPSTF’s ongoing efforts to develop clinical recommendations for effective preventive care. With the passage of the Patient Protection and Affordable Care Act, the USPSTF’s recommendations become more significant: recommendations with Grades A and B are statutorily mandated in Medicare, Medicaid, non-grandfathered commercial plans, and insurance sold on the state and federal marketplaces. In addition, the Centers for Medicare and Medicaid Services now has the ability not just to provide coverage for additional preventive services recommended by the USPSTF (as it has since 2008), but also to modify coverage of existing preventive services (such as Medical Nutrition Therapy).44 The Academy urges the USPSTF to finalize its recommendation giving due consideration to its statutory role and the manner in which the language of its recommendations has been and may be interpreted by regulatory authorities.

For example, this Draft Recommendation proposes to update the USPSTF’s 2003 Grade B recommendation for “Behavioral Counseling in Primary Care to Promote a Healthy Diet in Adults at Increased Risk for Cardiovascular Disease.”45 In 2003, the USPSTF recommended “intensive behavioral dietary counseling for adult patients with hyperlipidemia and other known risk factors for cardiovascular and diet-related chronic disease. Intensive counseling can be delivered by primary care clinicians or by referral to other specialists, such as nutritionists or dietitians.”46 However, when CMS decided to provide coverage for the new preventive service of Intensive Behavioral Therapy for Cardiovascular Disease in 2011, the substance of the covered benefit was fundamentally different from the USPSTF recommendations. Not only did this new coverage fail to cover explicitly recommended referrals to the most qualified, effective, and cost-effective providers of this therapy—registered dietitian nutritionists—but the limit of just one covered “face-to-face CVD risk reduction visit every two years” is wholly irreconcilable with the USPSTF’s recommendation for intensive behavioral dietary counseling.47

Given the statutory importance of and interpretive weight given to the USPSTF’s recommendation itself, the USPSTF should include explicit language for appropriate providers similar to the 2003 Recommendation for “referral to other specialists, such as nutritionists or dietitians.”48 Explicitly denoting the providers demonstrated effective in the relied-upon studies will best facilitate the substance of the USPSTF’s Draft Recommendation. The Academy appreciates the USPSTF’s recognition of its statutory ability to drive consequential, effective preventive care in this country, and we urge the USPSTF as it finalizes its recommendations to ensure to the extent possible that its recommended preventive services would be covered in substance and not in name only.

Lastly, we encourage the USPSTF to revise the terminology used in its recommendation to recognize the medical conditions/diseases of overweight and obesity by referring instead to “adults with overweight or obesity.”

Therefore, with consideration of the totality of the above comments, the Academy encourages the USPSTF to revise the language of the Draft Recommendation when finalized to:

The U.S. Preventive Services Task Force (USPSTF) recommends offering or referring adults with overweight or obesity who have additional cardiovascular disease (CVD) risk factors to intensive behavioral counseling interventions and Medical Nutrition Therapy (delivered by specialists such as a registered dietitian nutritionist or other nutrition professional) to promote a healthy diet and physical activity for CVD prevention.

The Academy appreciates the opportunity to comment on this important initiative; please contact either Jeanne Blankenship at 202-775-8277 ext. 6004 or by email at jblankenship@eatright.org or Pepin Tuma at 202-775-8277 ext. 6001 or by email at ptuma@eatright.org with any questions or requests for additional information.

Sincerely

Jeanne Blankenship, MS, RDN
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics

Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
Academy of Nutrition and Dietetics


1 U.S. Preventive Services Task Force website. Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors. Available at http://www.uspreventiveservicestaskforce.org/draftrec.htm. Accessed May 29, 2014.

2 The Academy recently approved the optional use of the credential “registered dietitian nutritionist (RDN)” by “registered dietitians (RDs)” to more accurately convey who they are and what they do as the nation’s food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.

3 “Medical Nutrition Therapy is an evidence-based application of the Nutrition Care Process. The provision of MNT (to a patient/client) may include one or more of the following: nutrition assessment/re-assessment, nutrition diagnosis, nutrition intervention, and nutrition monitoring and evaluation that typically results in the prvention, delay, or management of diseases and/or conditions.” CITE definition of terms list

4 U.S. Preventive Services Task Force website. Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors. Available at http://www.uspreventiveservicestaskforce.org/draftrec.htm. Accessed May 29, 2014.

5 Ibid.

6 USPSTF website. “Behavioral Counseling to Promote a Healthy Lifestyle for Cardiovascular Disease Prevention in Persons With Cardiovascular Risk Factors: A Systematic Evidence Review for the U.S. Preventive Services Task Force.” Accessed June 4, 2014 at http://www.uspreventiveservicestaskforce.org/uspstf13/cvdhighrisk/cvdhighriskdraftrep.pdf

7 Ibid. at v.

8 Academy of Nutrition and Dietetics. Evidence Analysis Library. Medical Nutrition Therapy Evidence Analysis Project 2008. Accessed May 2014, https://www.andevidencelibrary.com/topic.cfm?cat=3675. (“PrevT2DM: Coordination of Care; For individuals who are at high risk for type 2 diabetes, the registered dietitian nutritionist (RDN) should implement medical nutrition therapy (MNT) and coordinate care with a multi-disciplinary team and important others (e.g., family, friends and colleagues) in a wide variety of settings. This approach is necessary to effectively integrate MNT into overall management for individuals who are at high risk for type 2 diabetes. Rating: Strong. Imperative.”)

9 Committee on Nutrition Services for Medicare Beneficiaries. “The Role of Nutrition in Maintaining Health in the Nation’s Elderly: Evaluating Coverage of Nutrition Services for the Medicare Population.” Washington, DC: Food and Nutrition Board, Institute of Medicine; January 1, 2000 (published).

10 U.S. Preventive Services Task Force website. Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors. Available at http://www.uspreventiveservicestaskforce.org/draftrec.htm. Accessed May 29, 2014. The 2014 Evidence Review also examined individuals with the one or more of the following risk factors: dyslipidemia, hypertension, impaired fasting glucose/impaired glucose tolerance, and/or metabolic syndrome. USPSTF website. “Behavioral Counseling to Promote a Healthy Lifestyle for Cardiovascular Disease Prevention in Persons With Cardiovascular Risk Factors: A Systematic Evidence Review for the U.S. Preventive Services Task Force.” Accessed June 4, 2014 at http://www.uspreventiveservicestaskforce.org/uspstf13/cvdhighrisk/cvdhighriskdraftrep.pdf at 4.

11 U.S. Preventive Services Task Force website. Behavioral Counseling in Primary Care to Promote a Healthy Diet. Available at http://www.uspreventiveservicestaskforce.org/3rduspstf/diet/dietrr.htm. Accessed May 29, 2014.

12 USPSTF website. “Behavioral Counseling to Promote a Healthy Lifestyle for Cardiovascular Disease Prevention in Persons With Cardiovascular Risk Factors: A Systematic Evidence Review for the U.S. Preventive Services Task Force.” Accessed June 4, 2014 at http://www.uspreventiveservicestaskforce.org/uspstf13/cvdhighrisk/cvdhighriskdraftrep.pdf at 34

13 USPSTF website. “Behavioral Counseling to Promote a Healthy Lifestyle for Cardiovascular Disease Prevention in Persons With Cardiovascular Risk Factors: A Systematic Evidence Review for the U.S. Preventive Services Task Force.” Accessed June 4, 2014 at http://www.uspreventiveservicestaskforce.org/uspstf13/cvdhighrisk/cvdhighriskdraftrep.pdf at 38. 4

14 U.S. Preventive Services Task Force website. Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors. Available at http://www.uspreventiveservicestaskforce.org/draftrec.htm. Accessed May 29, 2014., citing Lin JS, O'Connor E, Evans CV, Senger CA, Rowland MG, Groom HC. Behavioral Counseling to Promote a Healthy Lifestyle for Cardiovascular Disease Prevention in Persons with Cardiovascular Risk Factors: A Systematic Evidence Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 113. AHRQ Publication No. 13-05179-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2014.

15 “Behavioral Counseling in Primary Care to Promote a Healthy Diet: Recommendations and Rationale.” USPSTF 2003, accessed 18 May 2014 http://www.uspreventiveservicestaskforce.org/3rduspstf/diet/dietrr.pdf.

16 Lin JS, O’Connor E, Whitlock EP, Beil TL. Behavioral Counseling to Promote Physical Activity and a Healthful Diet to Prevent Cardiovascular Disease in Adults: A Systematic Review for the U.S. Preventive Services Task Force. Ann Intern Med 2010;153:736-750.

17 U.S. Preventive Services Task Force website. Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors. Available at http://www.uspreventiveservicestaskforce.org/draftrec.htm. Accessed May 29, 2014.

18 U.S. Preventive Services Task Force website. Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors. Available at http://www.uspreventiveservicestaskforce.org/draftrec.htm. Accessed May 29, 2014.

19 USPSTF website. “Behavioral Counseling to Promote a Healthy Lifestyle for Cardiovascular Disease Prevention in Persons With Cardiovascular Risk Factors: A Systematic Evidence Review for the U.S. Preventive Services Task Force. Accessed June 4, 2014 at http://www.uspreventiveservicestaskforce.org/uspstf13/cvdhighrisk/cvdhighriskdraftrep.pdf at 4.

20 “Behavioral Counseling in Primary Care to Promote a Healthy Diet: Recommendations and Rationale,” U.S. Preventive Services Task Force2003, accessed 18 May 2014 http://www.uspreventiveservicestaskforce.org/3rduspstf/diet/dietrr.pdf

21 Committee on Nutrition Services for Medicare Beneficiaries. “The Role of Nutrition in Maintaining Health in the Nation’s Elderly: Evaluating Coverage of Nutrition Services for the Medicare Population.” Washington, DC: Food and Nutrition Board, Institute of Medicine; January 1, 2000 (published).

22 U.S. Preventive Services Task Force website. Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors. Available at http://www.uspreventiveservicestaskforce.org/draftrec.htm. Accessed May 29, 2014.

23 USPSTF website. “Behavioral Counseling to Promote a Healthy Lifestyle for Cardiovascular Disease Prevention in Persons With Cardiovascular Risk Factors: A Systematic Evidence Review for the U.S. Preventive Services Task Force.” Accessed June 4, 2014 at http://www.uspreventiveservicestaskforce.org/uspstf13/cvdhighrisk/cvdhighriskdraftrep.pdf at 13

24 U.S. Preventive Services Task Force website. Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors. Available at http://www.uspreventiveservicestaskforce.org/draftrec.htm. Accessed May 29, 2014.

25 U.S. Preventive Services Task Force website. Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors. Available at http://www.uspreventiveservicestaskforce.org/draftrec.htm. Accessed May 29, 2014.

26 USPSTF website. “Behavioral Counseling to Promote a Healthy Lifestyle for Cardiovascular Disease Prevention in Persons With Cardiovascular Risk Factors: A Systematic Evidence Review for the U.S. Preventive Services Task Force.” Accessed June 4, 2014 at http://www.uspreventiveservicestaskforce.org/uspstf13/cvdhighrisk/cvdhighriskdraftrep.pdf

27 Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 at 4.

28 Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2013; Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 (“The goals of the American College of Cardiology (ACC) and the American Heart Association (AHA) are to prevent cardiovascular (CV) diseases, improve the management of people who have these diseases through professional education and research, and develop guidelines, standards and policies that promote optimal patient care and CV health.”)

29 AHA/ACC Guidelines at 10 (“Weight loss and maintenance are critical for prevention and control of CVD risk factors. The Obesity Expert Panel is simultaneously performing a systematic review of the evidence for weight management and CVD risk factors and outcomes. The primary intent of the Work Group’s systematic review was to focus on the effects of diet and physical activity on CVD risk factors independent of effects on weight. Therefore, studies in which the primary outcome was weight loss or in which treatment was associated with more than 3% change in weight were excluded from the review. However, the Work Group expects that recommendations from both evidence reviews will apply to many patients.”)

30 Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2013.

31 The AHA/ACC/TOS Guidelines note that “[i]n a few cases, lay persons were used as trained interventionists; they received instruction in weight management protocols (designed by health professionals) in programs that have been validated in high quality trials published in peer-reviewed journals.” Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2013.

32 Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2013 at 20, 22.

33 Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2013.

34 Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 at 6.

35 U.S. Preventive Services Task Force website. Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors. Available at http://www.uspreventiveservicestaskforce.org/draftrec.htm. Accessed May 29, 2014.

36 Lin JS, O’Connor E, Whitlock EP, Beil TL, Zuber SP, Perdue LA, Plaut D, Lutz K. Behavioral counseling to promote physical activity and a healthful diet to prevent cardiovascular disease inn adults: update of the evidence for the U. S. Preventive Services Task Force. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Dec. Report No. 11-05149-EF-1.

37 Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation and Treatment of High Cholesterol in Adults (Adult Treatment Panel III)National Cholesterol Education Program, National Heart, Lung, and Blood Institute; National Institutes of Health, NIH Publication No. 02-5215, September 2002; American Heart Association Nutrition Committee, Lichtenstein AH, Appel LJ, Brands M, Carnethon M, Daniels S, Franch HA, Franklin B, Kris-Etherton P, Harris WS, Howard B, Karanja N, Lefevre M, Rudel L, Sacks F, Van Horn L, Winston M, Wylie-Rosett J. Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee. Circulation 2006 Jul 4;114(1):82-96;

38 Berglund L, Lefevre M, Ginsberg HN, Kris-Etherton PM, Elmer PJ, Stewart PW, Ershow A, Pearson TA, Dennis BH, Roheim PS, Ramakrishnan R, Reed R, Stewart K, Phillips KM; DELTA Investigators. Comparison of monounsaturated fat with carbohydrates as a replacement for saturated fat in subjects with a high metabolic risk profile: studies in the fasting and postprandial states. Am J Clin Nutr. 2007 Dec; 86 (6): 1,611-1,620.

39 Knopp RH, Fish B, Dowdy A, Retzlaff B, Walden C, Rusanu I, Paramsothy P. A moderate-fat diet for combined hyperlipidemia and metabolic syndrome. Curr Atheroscler Rep. 2006 Nov;8(6):492-500.

40 Musunuru K. Atherogenic dyslipidemia: cardiovascular risk and dietary intervention. Lipids. 2010 Oct;45(10):907-14.

41 Details of cited studies are provided in the Appendix.

42 Chobanian AV et al; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003 Dec;42(6):1206-52

43 Details of cited studies are found in the Appendix.

44 42 U.S.C. 1395(ddd).

45 “Behavioral Counseling in Primary Care to Promote a Healthy Diet: Recommendations and Rationale,” U.S. Preventive Services Task Force2003, accessed 18 May 2014 http://www.uspreventiveservicestaskforce.org/3rduspstf/diet/dietrr.pdf

46 Ibid. (Emphasis added.)

47 Centers for Medicare and Medicaid Services. Coverage details. Accessed May 29, 2014 at http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=348&ncdver=1&bc=AgAAgAAAAAAAAA%3d%3d&.

48 “Behavioral Counseling in Primary Care to Promote a Healthy Diet: Recommendations and Rationale,” U.S. Preventive Services Task Force2003, accessed 18 May 2014 http://www.uspreventiveservicestaskforce.org/3rduspstf/diet/dietrr.pdf


Appendix A

Additional References

Appel LJ, Espeland MA, Easter L, Wilson AC, Folmar S, Lacy CR. Effects of reduced sodium intake on hypertension control in older individuals: results from the Trial of Nonpharmacologic Interventions in the Elderly (TONE). Arch Intern Med. 2001 Mar 12; 161 (5): 685-693.

In the randomized controlled Trial of Nonpharmacologic Interventions in the Elderly (TONE, class A) in the United States, Appel et al, 2001, determined the effect of reduced sodium intake on blood pressure in 681 older patients with hypertension, aged 60 – 80 years. TONE interventions included an introductory individual session for those in the reduced sodium group within one month, an intensive phase with weekly group meetings for four months, an extended phase with biweekly group meetings for the next three months and a maintenance phase. Every fourth contact was an individual session, and the interventionists were typically registered dietitians. Prior to medication withdrawal, mean reductions in blood pressure from the reduced sodium intervention, net of control, were 4.33mm Hg (P<0.001) for systolic blood pressure and 2.0mm Hg (P=0.001) for diastolic blood pressure.

Henkin Y, Shai I, Zuk R, Brickner D, Zuilli I, Neumann L, Shany S. Dietary treatment of hypercholesterolemia: do dietitians do it better? A randomized, controlled trial. Am J Med. 2000 Nov;109(7):549-55.

In this 3-month, randomized clinical trial (class A), 136 participants (mean age 50 years ± 11) were assigned to either usual care by a physician or 2-4 nutrition counseling sessions with an RD. At 3 months, total cholesterol had decreased by 9% in the MNT group as compared to 5% in the control group (P<0.05). LDL-cholesterol had decreased by 12% in the MNT group as compared to 7% in the control group (P<0.05).

Holmes AL, Sanderson B, Maisiak R, Brown A, Bittner V. Dietitian services are associated with improved patient outcomes and the MEDFICTS dietary assessment questionnaire is a suitable outcome measure in cardiac rehabilitation. J Am Diet Assoc 2005;105(10):1533-1540.

In this retrospective cohort study (class B) in the United States, Holmes et al, 2005 examined the effectiveness of having a registered dietitian educating and counseling on diet-related patient outcomes compared with general education provided by the cardiac rehabilitation staff. Patients were encouraged to attend weekly small-group education classes, which were led by registered dietitians and focused on heart-healthy nutrition and label reading. Individual counseling was recommended to supplement the group education classes and general cardiac rehabilitation education when indicated. In this analysis, patients receiving any education and/or counseling from a registered dietitian were grouped together. Data on 426 patients (mean age 62 ± 11 years) with coronary heart disease who completed cardiac rehabilitation were abstracted from a Cardiac Rehabilitation Program outcomes database. At baseline, the subjects in the registered dietitian group (n=359) had significantly more dyslipidemia (88% versus 76%), more obesity (47% versus 27%), a higher waist circumference (40 ± 6 versus 37 ± 5 inches), a higher body mass index (30 ± 6 versus 27 ± 5 kg/m2), a higher diet score (32 ± 28 versus 19 ± 19), and lower self-reported physical activity (7 ± 12 versus 13 ± 18 metabolic equivalent hours) than the subjects in the general education group (n=67, all P < 0.05). Education from a registered dietitian was associated with improved LDL cholesterol (r=0.13, P = 0.04) and triglycerides (r=0.48, P= 0.01).

Pritchard DA, Hyndman J, Taba F. Nutritional counseling in general practice: A cost effective analysis. J Epidemiol Community Health. 1999; 53: 311-316.

In one positive-quality randomized controlled trial (class A) in Australia by Pritchard et al, 1999, 273 subjects (aged 25 to 65 years, 73% were under age 50) who were overweight or who had hypertension and type 2 diabetes were allocated to one of two intervention groups (doctor/dietitian or dietitian) or a control group. Both intervention groups received six counseling sessions over 12 months from a dietitian; the initial session was 45 minutes long, with 15 minutes for follow-up sessions. 177 subjects completed the study (65%), but the dropout rate of overweight patients in the dietitian group (45%) was significantly greater than the 29% for the doctor/dietitian group. Both intervention groups reduced weight and blood pressure compared to the control group. Compared to the control group, the cost of an extra kilogram of weight loss for the doctor/dietitian group was $9.76 and for the dietitian group was $7.30.

Shai I, Schwarzfuchs D, Henkin Y, Shahar DR, et al; Dietary Intervention Randomized Controlled Trial (DIRECT) Group. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. N Engl J Med. 2008 Jul 17;359(3):229-41. Erratum in: N Engl J Med. 2009 Dec 31;361(27):2681.

In a randomized, controlled 2 year trial (class A) with 322 participants (mean age 52 years), Shai et al, 2008 investigated the effects of three dietary interventions on BMI, blood lipid levels, and other cardiovascular risk factors. Participants were randomized to 1 of 3 diets: a VLC diet with no calorie restrictions; a calorie-restricted Mediterranean diet (MED); or a calorie-restricted LF diet. RDs conducted 90-minute dietary intervention group sessions for each intervention group once every two weeks for 8 weeks, then once every 6 weeks after that . During 2 year intervention, RDs also conducted 10-15 minute motivational telephone calls for participants having trouble with adherence approximately six times during the 2 year intervention. Statistically significant improvements were seen in HDL-cholesterol and triglycerides in all groups, along with reductions in blood pressure and BMI. The mean weight change was -4.7 kg for the VLC group, -4.4 kg for the MED group, and -2.9 kg for the LF group. The ratio of serum total cholesterol to HDL-C decreased in all groups, with the LC group showing the greatest improvement with a relative decrease of 20% compared with the LF group with a decrease of 12%.

Sikand G, Kashyap ML, Wong ND, Hsu JC. Dietitian intervention improves lipid values and saves medication costs in men with combined hyperlipidemia and a history of niacin noncompliance. J Am Diet Assoc. 2000; 100: 218-224.

In a positive-quality retrospective chart review (class B) in the United States, Sikand et al, 2000 conducted a cost-benefit analysis for 43 hyperlipidemic male patients (mean age 60.7 years) that were classified as niacin failures. Niacin failures were subjects that were non-compliant to taking niacin due to its side effects and were placed on a trial of MNT for eight weeks prior to beginning statin therapy (if needed). Patients had two to four individualized RD visits over eight-week period and subjects were following Step I NCEP diet. Average RD intervention time was three MNT sessions and 169 minutes during seven weeks of MNT. As a result, TC decreased -11% (P<0.001), LDL-C decreased 9% (P<0.001), TG decreased 22% (P<0.0001). HDL-C increased 4% however this was not statistically significant and BMI decreased 2% (P<0.0001) compared to baseline. As a result of MNT, 15 of 30 eligible patients did not need medication therapy which resulted in an annual cost savings of $638.35 per patient by avoiding the use of statins. A cost saving of $3.03 in statin therapy was realized for each $1 spent on MNT. Although given a high-quality rating, complete information was only available for 43 of 73 patients. Authors concluded that three visits of one hour each over an eight-week period had a significantly beneficial effect in treating patients with combined hyperlipidemia (high LDL-C and high triglyceride).

Sikand G, Kashyap ML, Yang I. Medical nutrition therapy lowers serum cholesterol and saves medication costs in men with hypercholesterolemia. J Am Diet Assoc. 1998; 98: 889-894.

In a positive-quality retrospective chart review (class B) in the United States, Sikand et al, 1998 completed a cost-benefit analysis based on 95 male VA patients with hyperlipidemia (high LDL) who participated in an eight-week nutrition intervention program. Subjects met criteria for initiating drug therapy (LDL-C 4.1mmol/L), were not on lipid-lowering medications, were 21-75 years of age (mean age 60.8 years), and had two to four RD visits over six to eight-week period. The initial visit was 60 minutes, the first follow-up visit four weeks later was 60 minutes and the remaining two follow-up visits were 30 minutes each. Complete medical records available for 74 of the 95 subjects were used for analysis. As a result of MNT, TC decreased -13.4% (P<0.0001), LDL-C decreased -14.2% (P<0.0001), TG decreased 10.8% (P<0.05), and HDL-C decreased -4.4% (P<0.05) compared to baseline. Average RD time was 144±21 minutes, 2.8±0.7 sessions, 6.8±0.7 weeks. LDL-C decreased more with four RD visits compared to two RD visits (-21.9% vs. -12.1%; P<0.027). Lipid drug eligibility was obviated in 34 of 67 (51%) of subjects with savings of $60,561.68 from not using the medications. A cost savings of $4.28 in statin therapy was realized for each $1 spent on MNT. Authors concluded that two to four individualized RD visits of 50 minutes each over seven weeks was associated with significant cholesterol decrease and a savings of health care dollars in avoiding the use of medications.